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Transcatheter Arterial Chemoembolization as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

Phase 4
18 Years
75 Years
Open (Enrolling)
Hepatocellular Carcinoma, Liver Cancer

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Trial Information

Transcatheter Arterial Chemoembolization as an Adjuvant Therapy After Radiofrequency Ablation for Hepatocellular Carcinoma

Local ablation is a safe and effective therapy for patients who cannot undergo resection, or
as a bridge to transplantation. Of the various percutaneous local ablative therapies,
radiofrequency ablation (RFA) has attracted the greatest interest because of its
effectiveness and safety for small HCC ≤ 5.0 cm, with a 3-year survival rate of 62% to 68%,
a low treatment morbidity of 0% to 12%, and a low treatment mortality of 0% to 1%.
Prospective randomized trials have shown RFA to be better than percutaneous ethanol
injection (PEI) in producing a higher rate of complete tumor necrosis with fewer numbers of
treatment sessions and better survival.

Unfortunately, the complete tumor necrosis rate for tumors larger than 5 cm is less
favorable, and the local recurrence rate can be as high as 20% even in small HCC less than
3.5 cm. The high local recurrence rate may be due to residual cancer cells not killed by RFA
or adjacent microscopic satellite tumor nodules.

Transcatheter Arterial Chemoembolization (TACE) has proven to be an effective and palliative
therapy for unresectable HCC. And some prospective randomized controlled trials have shown
that adjuvant TACE after curative resection for HCC can improve the overall survivals and
decrease the recurrence rates. But there have not been any studies about TACE as an adjuvant
therapy after RFA for HCC.

Thus, the purpose of this study is to prospectively evaluate whether TACE as an adjuvant
therapy after RFA for HCC will improve the outcomes of RFA.

Inclusion Criteria:

- Aged 18 - 75 years, and refused surgery

- A solitary HCC ≤ 7.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 3.0 cm in

- Lesions being visible on ultrasound (US) and with an acceptable/safe path between the
lesion and the skin as shown on US

- No extrahepatic metastasis

- No imaging evidence of invasion into the major portal/hepatic vein branches

- No history of encephalopathy, ascites refractory to diuretics or variceal bleeding

- A platelet count of > 40,000/mm3

- No previous treatment of HCC except liver resection

Exclusion Criteria:

- Patient compliance is poor

- The blood supply of tumor lesions is absolutely poor or arterial-venous shunt so that
TACE cannot be performed

- Previous or concurrent cancer that is distinct in primary site or histology from HCC,
EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder
tumors (Ta, Tis and T1). Any cancer curatively treated > 3 years prior to entry is

- History of cardiac disease:

- congestive heart failure > New York Heart Association (NYHA) class 2

- active coronary artery disease (myocardial infarction more than 6 months prior
to study entry is permitted)

- cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers,
calcium channel blocker or digoxin

- uncontrolled hypertension (failure of diastolic blood pressure to fall below 90
mmHg, despite the use of 3 antihypertensive drugs).

- Active clinically serious infections (> grade 2 National Cancer Institute
[NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)

- Known history of human immunodeficiency virus (HIV) infection

- Known central nervous system tumors including metastatic brain disease

- Patients with clinically significant gastrointestinal bleeding within 30 days prior
to study entry

- Distantly extrahepatic metastasis

- History of organ allograft

- Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

- Known or suspected allergy to the investigational agent or any agent given in
association with this trial

- Any condition that is unstable or which could jeopardize the safety of the patient
and his/her compliance in the study

- Pregnant or breast-feeding patients. Women of childbearing potential must have a
negative pregnancy test performed within seven days prior to the start of study drug.
Both men and women enrolled in this trial must use adequate barrier birth control
measures during the course of the trial.

- Excluded therapies and medications, previous and concomitant:

- Prior use of any systemic anti-cancer treatment for HCC, eg. chemotherapy,
immunotherapy or hormonal therapy (except that hormonal therapy for supportive
care is permitted). Antiviral treatment is allowed, however interferon therapy
must be stopped at least 4 weeks prior to randomization.

- Prior use of systemic investigational agents for HCC

- Autologous bone marrow transplant or stem cell rescue within four months of
start of study drug

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survivals

Outcome Time Frame:

3, and 5-years

Safety Issue:


Principal Investigator

Min-Shan Chen, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University


China: Ministry of Health

Study ID:




Start Date:

November 2007

Completion Date:

June 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • hepatocellular carcinoma
  • liver cancer
  • radiofrequency ablation
  • transcatheter arterial chemoembolization
  • adjuvant therapy
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular